This invention relates, in part, to therapeutic compositions which exhibit unexpected effectiveness in the treatment of certain virus-induced and autoimmunological medical disorders. The process for the preparation of such therapeutic compositions and the treatment of disease therewith are also included within the scope of the invention.
The present invention, while of general application, has proven particularly effective in the treatment of Type 1 Diabetes Mellitus. This disease is also known as "Juvenile Onset Diabetes Mellitus" or "Insulin Dependent Diabetes Mellitus" and will hereinafter be referred to as "Type 1 Diabetes". The disease is characterized by the destruction of pancreatic beta cells which normally produce and secrete the sugar regulatory hormone insulin. It is believed that compositions in accordance with the invention, when introduced into the bloodstream of Type 1 diabetics, effectively attenuate beta cell destruction. When Type 1 Diabetes is diagnosed before substantial beta cell destruction has taken place, a patient may avoid dependency on external source insulin by undergoing treatment with the therapeutic compositions of the instant inventions. Through such treatment, it is believed that the pancreatic beta cells are preserved such that they can continue to produce and secrete natural insulin thereby regulating body sugar levels.
In addition to the attendant significant discomfort, inconvenience and cost to a patient dependent on external source insulin, Type 1 Diabetes has also been found to lead to a multitude of other serious disorders resulting from sugar imbalances which cannot be completely controlled using external source insulin. Stiller et al. report in Science, volume 223 (1984) at page 1362 that the mortality rate of Type 1 diabetics is abnormally high four decades after the initial diagnosis is made. They also report an uncommonly high frequency of blindness, gangrene, and strokes.
It is widely believed that Type 1 Diabetes is caused by a virus or an autoimmune response possibly triggered by a virus. (See, for instance, Cudworth, Andrew G. and Andrew N. Gorsuch, "Autoimmunity and Viruses in Type 1 (Insulin-Dependent) Diabetes", Diabetes Mellitus, Theory and Practice (third ed. 1984), pp. 505-517.) Because of mounting evidence that beta cell destruction is caused by an autoimmune response, researchers have been led to working with immunosuppressants to determine their effectiveness in arresting beta cell destruction and restoring acceptable levels of endogenous insulin production.
In their Science article referred to above, Stiller et al. reported the testing of the immunosuppressive agent Cyclosporine on recently diagnosed Type 1 Diabetics. An encouragingly significant percentage of patients, especially those for whom treatment had begun very shortly after diagnosis, achieved independence from external source insulin. Unfortunately, use of Cyclosporine was also observed to cause serious undesirable side effects resulting from immunosuppression such as pancytopenia, cirrhosis of the liver, and loss of hair.
Others have employed antithymocyte sera to suppress beta cell destruction but with only weak responses. More conventional treatments for Type 1 Diabetes, the most common of which is the introduction of externally produced insulin, merely offset some of the undesirable consequences of the disease and are not successful in arresting the disease process. Additionally, external source insulin must be injected daily and, as a result, causes the patient great discomfort and is expensive.
It is an object of the invention to provide therapeutic compositions effective in the treatment of virus-induced and autoimmune diseases and a process for their preparation.
It is also an object of the present invention to provide a therapeutic composition effective in attenuating and arresting the destruction of pancreatic beta cells.
Another object of the invention is to provide a therapeutic composition for the treatment of Type 1 Diabetes with few, or no, undesirable side effects.
A further object is to provide a treatment for Type 1 Diabetes and other diseases, which is economical, convenient, and reliable.